The purpose of this research project was to determine the broncholytic action of SFC.

Materials and methods

The research was conducted at Krasivo, a health resort located in Belgorod Region. 154 people with bronchial obstructive syndrome aged 18 to 80 years old (95 patients with BA, 46 with a chronic obstructive lung disease (COLD) and 13 with acute tracheitis) were examined. COLD and BA were diagnosed in accordance with the requirements of the formulary system which provisions are laid down in the Order of the Ministry of Health of the Russian Federation dated October 9, 1998 (Order № 300 “On Standards (Protocols) of Diagnostics and Treatment of Patients with a Chronic Obstruction Lung Disease”), while acute tracheitis was diagnosed based on clinical signs.

The control group included 44 patients aged 18 to 80 years old with BA in their anamneses who used low-mineralized hydrocarbonate sodium water “Krasivo” to prevent the mineral composition of the water used as a solvent for SFC from impacting airway conductance.

External respiration function (ERF) examination with determining FEV-1 levels characterizing bronchial tree conductance was performed by means of spirography with the use of a diagnostic system “Valenta” with further computer processing of the data recorded.

Karelian shungite was used as a source of SFC. The shungite had the following mineral composition (% of its mass) (Table 1): shungite carbon – 28, quartz – 50, complex silicates (micas, chlorite) – 17, sulfides – 2, other minerals – 3. The products provided to the health resort by “Karelia-Shungite”, Ltd. were produced by “Environmental Safety”, KROO (TU 5714-007-12862296-01) and had a sanitary-epidemiological certificate № 10. КЦ 03.571. П. 0004 07.27.02.

Table 1

Chemical composition of shungite, % of its mass (Khadartsev and others, 2005)

SiO2

TiO2

Al2O3

FeO

MgO

CaO

Na2O

K2O

S

C

H2O crys.

57.0

0.2

4.0

2.5

1.2

0.3

0.2

1.5

1.2

29.0

4.2

A 0.10 mg/ml SFC solution which was the first to be used for treating patients suffering from bronchial obstructive syndrome with various etiologies was made in accordance with the guidelines of “Karelia-Shungite”, NPP. The solution was applied in the form of inhalations with the use of a “Musson-1” apparatus. Inhalation duration was 10 minutes and inhalation volume was 5 ml.; one course of treatment included 7-14 inhalations.

As part of the research project, a blank experiment was performed with mineral water inhalations for treating patients with BA without globular carbon in order to prevent the water mineral composition from impacting airway conductance.

Statistical analysis included descriptive data acquisition such as average and standard deviations and confidence intervals. Comparative analysis was conducted with the use of the Student’s test (Kashin, 1994).

Research methodology

In the beginning, basal airway conductance values of each patient under study regarding their FEV-1 levels were measured, and after inhaling a SFC solution in 40-60 minutes spirometry was performed again. The next stage was a test with the use of a traditional broncholytic preparation (such as salbutamol, berotec, atrovent) and in 40 minutes bronchial tree conductance was measured again to determine the broncholytic action of globular carbon. FEV-1 measurement was performed on the second and third or fourth day depending on the results of the initial tests and clinical dynamics, as well as at the end of the course of treatment.

Bronchial tree conductance based on FEV-1 levels depending on the broncholytic preparation applied in patients with BA, COLD and acute tracheitis (%)

bronchial obstructive syndrome

Basal FEV-1 values

FEV-1 after a SFC inhalation

FEV-1 after a salbutamol inhalation

FEV-1 after a mineral water inhalation

BA (n=95)

63.5±4.84

85.8±4.97*

85.6±4.08*

-

COLD (n=46)

67.3±4.92

71.1±4.97

70.2±4.94

-

Acute tracheitis (n=13)

69.7±4.36

88.4±4.44*

87.6±4.39*

-

Control (n=44)

65.7±4.27

-

-

67.9±4.32

Note: * – differences are valid as compared with the basal FEV-1 values in the corresponding groups.

SFC therapy was performed in the form of monotherapy for treating 140 patients and was combined with basic anti-inflammatory treatment with glucocorticosteroids (spray, daily dose – 800 mkg of flixotide) and application of long-acting B2-adrenergic agonists (serevent, 100 mkg/day) for treating 14 patients suffering from BA due to their high disease severity.

FEV-1 in 89 patients with BA after the first inhalation increased by 22.3 ± 0.96% (Table 2. 63.5±4.84%-85.8±4.97%) and only in 6 patients after the third or fourth inhalation which can be explained by the fact that they also had an acute viral respiratory infection. Tests conducted with the use of traditional broncholytic preparations after globular carbon inhalations did not cause further increase in their FEV-1 levels (85.8±4.97%-85.6±4.08%) which indicates an evident broncholytic action of SFC which is not inferior to traditional broncholytic preparations. FEV-1 levels in all patients with BA correlated with the positive clinical dynamics (significant reduction in the number and severity of expiratory dyspnea attacks or their complete disappearance, increased tolerance to physical exercise, etc.) It should be noted that with regard to the patients with BA whose severe condition was caused by the fact that they also had an acute viral respiratory infection, their viral infectious disease had a milder clinical course and the patients recovered in 4-5 days without having to use antiviral and other drugs which can be explained by the well-known therapeutic properties of SFC which has been stated above.

A similar situation was seen in 13 patients with acute tracheitis (Table 2. 69.7±4.36%-88.4±4.44%), however the broncholytic action occurred after the first inhalation.

No significant increase in FEV-1 levels was seen in 41 patients with chronic obstructive bronchitis (12% and more) (67.3±4.92-71.1±4.97%) and only 5 patients demonstrated an increase by 12.2 ±1.06 % at the end of the course of treatment (Table 2) which, perhaps, is due to both the specifics of the disease which is characterized by the limited air flow speed which is reversible not completely unlike BA, and the fact that only a short course of treatment is available in the health resort. Nonetheless, positive clinical dynamics was seen in all patients characterized by improved expiratory dyspnea and expectoration of the sputa, significant cough reduction or relief, and improved tolerance to physical exercise; the latter, provided no increase in their FEV-1 levels is observed, may be caused by an improved ventilation-perfusion correlation.

As indicated above, SFC therapy was combined with inhalation glucocorticosteroids and long-acting B2-adrenergic agonists for treating 14 patients with BA. By the end of the course of treatment (14 inhalations) the dose of these drugs was reduced by half. Further case monitoring outside the health resort did not lead to a worsened clinical course.

The control group included 44 people (21 male and 23 female patients) aged 18 to 80 years old with BA in their anamneses with broncho-obstruction (FEV-1 was 65.7± 2.27 %) at the time of the examination. Mineral water inhalations did not cause changes in this group’s FEV-1 levels (Table 2. 65.7± 2.27 %-67.9±4.32%).

Thus, SFC has a bronchodilator action which is not inferior to other bronchodilator medications and can be applied in the following clinical cases:

Conducting bronchodilator (broncholytic) tests;

Prophylactics and treatment of bronchial obstructive syndrome in patients suffering from COLD and BA during pandemic periods;

Treatment of the specified patients in order to take under control the clinical course of the disease and for medicine dose reduction.

Analysis of literature and clinical experience indicates an important role of SFC in pathogenetic therapy of respiratory diseases with bronchial obstructive syndrome which, however, is not completely clear yet. Further studying of this problem may help develop new approaches to treatment, rehabilitation, and prophylactics of this pathology.